Controlling acoustic modes in tissue healing applications

ABSTRACT

A modal converter assembly for healing tissue, the modal converter assembly comprises a transducer and a body. The transducer is configured to transmit acoustic waves into the tissue from a tissue surface. The body is configured to house the transducer above the tissue surface such that the acoustic waves transmitted into the tissue are transmitted at an oblique angle relative to the tissue surface. The acoustic waves are transferred as shear waves and longitudinal waves to treat a damaged portion of the tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/296,333, filed Apr. 27, 2009, now allowed, which is a national stageapplication under 35 U.S.C. 371 of PCT/US2007/66197, filed Apr. 7, 2007,which claims priority from U.S. Provisional Patent Application60/790,502 filed Apr. 7, 2006, titled “Controlling Acoustic Modes inTissue Healing Applications” and U.S. Provisional Patent Application60/870,934 filed Dec. 20, 2006, titled “Angle Dependence of LowIntensity Pulsed Ultrasound Transmission in Bone.” The applications areherein incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to therapeutic ultrasound devices fortreating a human body and, more particularly, to controlling the anglesat which the acoustic waves are delivered from a transducer to the humanbody.

2. Related Art

Ultrasound has been used as a therapeutic technique in physical medicinefor over 45 years. It has been a recommended treatment technique foradjunctive therapy for the treatment of pain, soft tissue injury, andjoint dysfunction including osteoarthritis, periarthritis, bursitis,tenosynovitis, and a variety of musculoskeletal syndromes. Additionally,ultrasound has been used in applications such as acceleration of woundhealing, phonophoresis of topical drugs, treatment of scar tissue, andtreatment of sports injuries.

The therapeutic biological effects of ultrasound may be characterizedinto two major areas: thermal and nonthermal. The nonthermal effects caninclude acoustic streaming, cavitation, and other mechanical effectsover the broad range of ultrasonic frequencies from about 0.05 MHz(megahertz) to about 5.0 MHz. The electrical output from a signalgenerator is converted into mechanical vibration through a transducerwhich is generally made of a piezoelectric material such as leadzirconate titanate (PZT), single-crystal ferroelectric relax ors such asPMN-PZ-PT, or the like. The mechanical vibration produces an acousticwave which travels through the tissue and is absorbed in the propagatingprocess. The rate of viscous absorption and the associated increase intemperature are dependent on the micro-structural properties of thetissue-type encountered, the frequency of the acoustic wave, thespatial-temporal acoustic intensity and the degree of nonlinearpropagation in tissue. The acoustic energy may be in the form of acontinuous wave or a pulsed wave, depending on the therapeuticapplication, and is typically transferred from the transducer to thepatient's tissue using an acoustic coupling material, such as anultrasonic gel, lotion, hydrogel, or water. Acoustic intensities of 0.03to 3.0 W/cm² (Watts per square centimeter) are typically applied fortherapeutic purposes, in pulsed or continuous modes, allowing treatmentof bone fractures and acute, as well as chronic, tissue injury.

Typically, therapeutic ultrasound treatment is administered by utilizinga piezoelectric transducer normal to the skin tissue interface togenerate acoustic longitudinal waves that propagate in tissue, primarilyas longitudinal waves, to the treatment area. If the incidentlongitudinal waves are not normal to the piezoelectric transducer/skintissue interface, the resulting refracted acoustic waves in thesubsequent soft tissue propagate as quasi-longitudinal waves andquasi-shear waves at various refraction angles. As a result, it is oftendifficult to administer the acoustic waves to patients in the desiredalignment with the targeted tissue area using the means for therapeuticultrasound devices that are currently available.

International Publication No. WO 03/013654A1 taught that shear andlongitudinal waves could be controlled and delivered to a tissue bymeans of a modal converter in the form of a trapezoidal shapedcross-section of a low viscous loss material. The modal converter is alarge block of rubber that needs ultrasound coupling gel between thetissue surface area and the rubber block. The shape and design of such ablock is difficult to position and restrain on a patient to allowconsistent delivery of ultrasound. In addition, the placement of thetransducer and the rubber block in relation to the injury requires thecenter of the block to be offset from the fracture, which iscounter-intuitive for most people applying the device to a fracture. Theacoustic requirements for this rubber block are such that the materialis highly attenuating and requires a much higher incident intensity tobe delivered to the first face of the block and has a substantial drainon the battery life of the device and thus on its usability.

Although International Publication No. WO 03/013654A1 explains how tomaximize longitudinal and shear waves along the surface of the bone toaccelerate periosteal healing, it does not consider the importance ofshear waves for the other processes involved in tissue repair.Periosteal direct bone formation is one of the key processes involved infracture repair, but bone and tissue healing is not limited to only thatprocess. If it is important to provide longitudinal and shear waves toaid specific types of tissue healing, then it would also be important toidentify critical angles that result in the desired type of tissuehealing.

There remains a need in the art for improved methods and systems fordelivering ultrasonic waves to damaged tissue. Further, there remains aneed in the art for methods and systems that use ultrasonic wavesapplied at critical angles to achieve specific types of tissue healing.

SUMMARY OF THE INVENTION

An aspect of the invention provides a modal converter assembly forhealing tissue. The modal converter assembly comprises a transducer anda body. The transducer is configured to transmit acoustic waves into thetissue from a tissue surface. The body is configured to house thetransducer above the tissue surface such that the acoustic wavestransmitted into the tissue are transmitted at an oblique angle relativeto the tissue surface. The acoustic waves are transferred as shear wavesand longitudinal waves to treat a damaged portion of the tissue.

An embodiment of the invention provides a modal converter assemblywherein the transducer is a piezoelectric element.

Another embodiment of the invention further comprises a modal converterbeing made of a material having a speed of sound similar to the speed ofsound of the soft tissue. The modal converter is placed within the bodyand between the transducer and the soft tissue such that the anglebetween the transducer and the tissue surface is an oblique angle.

Another embodiment of the invention further comprises a springconfigured to bias the transducer toward the tissue surface.

Yet another embodiment of the invention further comprises a capconfigured to attach to the body. The spring has a first end and asecond end. The first end is attached to the cap and the second end isattached to the transducer.

Another embodiment of the invention provides a modal converter assemblywherein the transducer comprises a plurality of acoustic wave generatingelements. The plurality of acoustic wave generating elements areoriented along the tissue surface.

Another embodiment of the invention further comprises a signalgenerator. The signal generator is configured to control the acousticwaves generated in the transducer.

Another embodiment of the invention provides a modal converter assemblywherein acoustic waves are temporally shifted such that the sum of theacoustic waves transmitted into the tissue are transmitted at an obliqueangle relative to the tissue surface.

Another embodiment of the invention provides a modal converter assemblywherein the oblique angle is in the range from about 18 to 71 degreesfrom normal.

Another aspect of the invention provides a modal converter assembly forhealing tissue. The modal converter assembly comprises a transducer, abody, and a modal converter. The transducer is configured to transmitacoustic waves into the tissue from a tissue surface. The body isconfigured to house the transducer above the tissue surface. The modalconverter is made of a material having a speed of sound similar to thespeed of sound of the soft tissue. The modal converter is placed withinthe body and between the transducer and the soft tissue such that theangle between the transducer and the tissue surface is an oblique angle.The acoustic waves are transferred as shear waves and longitudinal wavesto treat a damaged portion of the tissue.

Another aspect of the invention provides a modal converter assembly forhealing tissue. The modal converter assembly comprises a transducer anda body. The transducer includes a plurality of acoustic wave generatingelements configured to transmit acoustic waves into the tissue from atissue surface. The plurality of acoustic wave generating elements areoriented along the tissue surface. The body is configured to house thetransducer above the tissue surface such that the acoustic wavestransmitted into the tissue are transmitted at an oblique angle relativeto the tissue surface. The acoustic waves are transferred as shear wavesand longitudinal waves to treat a damaged portion of the tissue.

Yet another aspect of the invention provides a modal converter assemblyfor healing tissue. The modal converter assembly comprises a transducerand a body. The transducer is configured to transmit acoustic waves intothe tissue from a tissue surface. The body is configured to house thetransducer above the tissue surface such that the acoustic wavestransmitted into the tissue are transmitted at an oblique angle relativeto the tissue surface. The acoustic waves are temporally shifted suchthat the sum of the acoustic waves transmitted into the tissue aretransmitted at an oblique angle relative to the tissue surface. Theacoustic waves are transferred as shear waves and longitudinal waves totreat a damaged portion of the tissue.

Yet another aspect of the invention provides a method for treatingtissue. The method orients a transducer over a tissue surface. Themethod rotates the transducer relative to the tissue surface. The methodalso transmits an acoustic wave into the tissue. The acoustic waves aretransmitted at an oblique angle relative to the tissue surface. Theacoustic waves are transferred as shear waves and longitudinal waves totreat a damaged portion of the tissue.

An advantage of the invention provides healing of tissue by implementingacoustical waves at an oblique angle to the tissue surface. At obliqueangles, shear waves or a combination of shear waves and longitudinalwaves may treat a damaged portion of the tissue.

Further areas of applicability of the present invention will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the invention, are intended forpurposes of illustration only and are not intended to limit the scope ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 is a cross-sectional side view of a first embodiment of a modalconverter assembly;

FIG. 2 is a top view of a body of the modal converter assembly;

FIG. 3 is a side view of the body shown in FIG. 2;

FIG. 4 is a perspective view of the body shown in FIG. 2;

FIG. 5 is a cross-sectional side view of the body shown in FIG. 2;

FIG. 6 is a graph illustrating longitudinal and shear waves;

FIG. 7 is a graph comparing longitudinal and shear waves;

FIG. 8 is a second embodiment of the modal converter assembly;

FIG. 9 is a third embodiment of the modal converter assembly;

FIG. 10 is a fourth embodiment of the modal converter assembly; and

FIG. 11 is a fifth embodiment of the modal converter assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the invention,its application, or uses.

FIGS. 1-5 illustrate a modal converter assembly 10 to deliver ultrasoundwaves into a medium B which may be composed of soft tissue and/or bone.The ultrasound waves promote healing of a wound in the soft issue and/orhealing of a fracture in the bone. The modal converter assembly 10includes a cap 2, a spring 4, a transducer 5, a base 7, a body 8, and amodal converter 9. The cap 2, base 7, and body 8 form a housingstructure to house the transducer 5, spring 4, and modal converter 9.The transducer 5 is electrically coupled to a signal generator 19 andcontroller 18 to control wave propagation through the modal converter 9and the medium B.

In the depicted embodiments, the base 7 is shown assuming that theinterface with the medium B is flat. However, those skilled in the artwould understand that the base 7 can be shaped to fit the interface withmedium B at a position above medium B where the generation of shearwaves is controlled. For example, the base 7 may be curved to fit overan arm or a leg of a patient, or may be irregularly shaped to fit overirregular surfaces.

In some embodiments, the base 7 includes an aperture 3, such as a holeor slot. The aperture 3 may be used to store the modal converterassembly 10 or to attach the base 7 to the medium B. In addition, theaperture may be used as a locator for positioning the modal converterassembly 10 over the medium B. The base 7, in the embodiments of FIGS.1-5, has dimensions F, G, and K. Dimension F is about 102 millimeters,dimension G is about 38 millimeters, and dimension K is about 1.5millimeters. Such an embodiment may be easily wielded and manageableover the majority of body surfaces, other dimensions may be used forbody surfaces that may require smaller or larger dimensions of the modalconverter assembly 10. The body 8 is shaped to receive the transducer 5.

The transducer 5 is constructed of materials and designs that arecommonly used in ultrasound applications. The transducer 5 may havepiezoelectric properties and may be made from, as examples, a ceramicmaterial, a single-crystal relaxor ferroelectric, lead zirconatetitanate, lead metaniobate, barium titanate, and piezoelectricco-polymers of polyvinylidene fluoride (PVDF). Alternatively, thetransducer 5 may have magnetostrictive properties. The transducer 5generates an ultrasound wave to be transmitted into the medium B via themodal converter 9. The ultrasound waves are generated from a drivingsignal received in the transducer 5 through the signal generator 19. Thespring 4 biases the transducer 5 against the modal converter 9 so thatthe ultrasound waves travel from the transducer 5 through the modalconverter 9 and into the medium B.

In the embodiment depicted in FIGS. 1-5, the body 8 is a cylindrical,hollow tube, as the transducer 5 has a circular cross-section, but othershapes may be used. The body 8 has an inner portion 14 and an outerportion 15. In the embodiments depicted in FIGS. 1-5, the body 8 has aninner wall 12 and an outer wall 13 which define the inner portion 14 andthe outer portion 15, respectively. The inner wall 12 of the body 8 isdimensioned such that the transducer 5 fits tightly within the body 8.The inner wall 12 may have a diameter the same as or slightly largerthan the diameter of the transducer 5. For example, the diameter of theinner wall 12 may be about 0 to about 2 mm larger than the diameter ofthe transducer 5. The body 8 also has a proximal end 16 and a distal end17. The cap 2 is connected to the body 8 at the distal end 17. Forexample, the body 8 may have a lip 11 such that the cap 2 snaps onto thebody 8. Further, the spring 4 is mounted between the cap 2 and thetransducer 5 in order to exert pressure and positively bias thetransducer 5. In some embodiments, the spring 4 may be mounted to thecap 2. The spring 4 biases the transducer 5 toward the proximal end 16of the body 8. The body 8 is mounted at an oblique angle A relative tothe base 7. The body 8 has dimensions H and J. In the embodimentdepicted in FIGS. 1-5, dimension H is about 33 millimeters and dimensionJ is about 31 millimeters but other dimensions may be used.

The modal converter 9 may be composed of suitable low attenuationmaterials which include, but are not limited to, thermoplastics,thermosets, elastomers and mixtures thereof. Useful thermoplasticsinclude, but are not limited to, ethyl vinyl acetate, available from USICorp (c/o Plastic Systems, Marlboro, Mass.), ecothane CPC 41, availablefrom Emerson and Cumming (Deway and Almay Chemical division, Canton,Mass.), and polyurethane RP 6400, available from Ren Plastics (aDivision of Ciba Geigy, Fountain Valley, Calif.). Useful thermosetsinclude, but are not limited to, epoxies such as Spurr epoxy, availablefrom Ernest F. Fullam, Inc. (Schenectady, N.Y.) and Stycast, availablefrom Emerson and Cumming. Other thermosets may include polymerizedesters of acrylic acid, such as n-octyl ester of acrylic acid, n-nonylester of acrylic acid, or 2-ethyl pentyl acrylate. Useful elastomersinclude, but are not limited to, RTV 60 and RTV 90, which are availablefrom General Electric (Silicon Products Division, Waterford, N.Y.).Other elastomers may include natural rubber, synthetic rubber, such asoil-filled and peroxide-cured cis-butadiene rubber, or gel pad material,such as polyglycerol hydrogel.

The modal converter 9 is fitted between the transducer 5 and the mediumB. The modal converter 9 may have a low ultrasound attenuation and speedof sound similar to that of soft tissue. The bottom surface of the modalconverter 9 that is in contact with the medium B is at an oblique anglerelative to the body 8. The dimension E of the modal converter 9 is suchthat the spring 4 exerts at least some pressure on the transducer 5. Twothin layers of coupling material, such as hydrogel, mineral oil, orwater, are applied to ensure that the maximum ultrasound power getstransmitted into the tissue from the transducer 5. A first layer 1 isapplied between the transducer 5 and the modal converter 9. A secondlayer 6 is applied between the modal converter 9 and the medium B.

The modal converter 9 is acoustically coupled to the transducer 5 withthe first layer 1 having an acoustic impedance comparable to theacoustic impedance of the modal converter 9, preferably an acousticimpedance within plus or minus ten percent of the acoustic impedance ofthe modal converter 9. In some embodiments, the acoustic impedance ofthe modal converter 9 is almost equal to that of human soft tissue.Additionally, the modal converter 9 is composed of materials preferablyhaving a longitudinal velocity that is less than the longitudinalvelocity for human musculo- skeletal soft tissue and that is less thanthe longitudinal velocity for bone tissue.

The acoustic waves which emanate from the transducer 5 are controlledspatially and temporally by the system controller 18. The design andfabrication of the system controller 18 are well known to those whopractice the art. The system controller 18 is electrically connected tothe signal generator 19, and the signal generator 19 is electricallyconnected to the transducer 5. The system controller 18 triggers theprogrammable signal generator 19 to produce ultrasonic excitationsignals that are sent to the transducer 5. The transducer 5 receives theexcitation signal and emits an acoustic longitudinal wave thatpropagates through the modal converter material 9 and on to medium B.

The transducer 5 produces specific sequential or simultaneoustransmissions of acoustic waves, controlled by the system controller 18,in order to noninvasively irradiate or interrogate the medium Bultrasonically. The system controller 18 may be a programmablemicroprocessor, but may also include, though is not limited to,integrated circuits, analog devices, programmable logic devices,personal computers or servers. The timing sequences may be establishedby the user at any time or established during the manufacturing process.

The modal converter assembly 10 may be used to administer therapeutictreatment composed of an ultrasound dosage administered once or twice aday, and repeated daily for several months to effectively stimulate thehealing process. In some embodiments, one dosage of acoustic wavesranges between 1 and 60 minutes in length for the transducer 5. Themodal converter assembly 10 may be used to facilitate and enhanceapplication of therapeutic ultrasound dosages to shallow or deepanatomical structures, or both, in an effort to expedite tissue woundhealing, including both the endosteal and periosteal healing phases inthe bone fracture healing process.

FIG. 6 graphically illustrates incident waves IW onto an interfacebetween soft tissue and bone and the resulting reflected waves RW,refracted shear waves W, and refracted longitudinal waves V. Ultrasonicwaves emanate from the transducer 5 (not shown in FIG. 6), travelthrough the modal converter 9, which is at an angle Θ with respect tothe normal, and enter into a first medium, such as soft tissue, as theincident wave IW at an angle θ. The incident wave IW continues throughthe first medium until it reaches a second medium, such as bone. At thatpoint, a portion of the incident wave IW is reflected off the secondmedium as the reflected wave RW at an angle Φ, a portion is refracted asthe refracted shear wave W at an angle γ, and a portion is refracted asthe longitudinal wave V at an angle β. As it is believed that refractedshear waves W and refracted longitudinal waves V promote different typesof healing, it is important to identify critical angles of γ and β thatmaximize the respective type of wave. By identifying the critical anglesand comparing the critical angles to the corresponding angle θ of theincident wave IW, the modal converter 9 can be constructed and arrangedto provide predetermined specific types of healing or combinationsthereof.

FIG. 7 graphically illustrates an exemplary method of determining themodal converter angle Θ for a desired amount of shear waves W (best seenin FIG. 6) and/or longitudinal waves V (best seen in FIG. 6). Four plotsare included in the graph showing the angle at which the refracted wavestravel in medium 2 (bone) assuming four different combinations ofmaterial properties for soft tissue, bone and the modal converter. Forexample, if only shear waves W parallel to the interface were desired,the modal converter angle Θ would be selected to be about 60 degrees.However, if only shear waves W into the medium were desired, the modalconverter angle Θ would be selected to be about 55 degrees. If acombination of shear waves W and longitudinal waves V into the mediumare desired, the angle Θ of the modal converter 9 would be selected tobe about 35 degrees. However, FIG. 7 is only exemplary as the relevantangles depend largely upon the material of the modal converter, thematerial of the second medium, and may further depend upon the geometryof the interface between each material. Assuming sound waves travelthrough the modal converter material at a speed of about 1390 msec,longitudinal sound waves travel through the second medium at a speed inthe range of about 3000 msec to about 3800 msec, and shear sound wavestravel through the second medium at a speed in the range of about 1630msec to about 1890 msec, the actual critical angles have been determinedto be from about 22 to about 28 degrees to maximize longitudinal waves Vtraveling parallel to the interface between the first and second media,from about 48 to about 59 degrees to maximize shear waves W travelingparallel to the interface, and from about 36 to about 41 degrees tomaximize the combination of longitudinal waves V traveling parallel tothe interface and shear waves W traveling into the second medium. Ingeneral, the range of the modal converter angle to achieve longitudinalwaves is from about 9 degrees to about 71 degrees, whereas the range ofthe modal converter angle to achieve shear waves is from about 18degrees to about 76 degrees.

FIG. 8 illustrates a second embodiment of the modal converter assembly,generally indicated by reference numeral 100. The modal converterassembly 100 includes a transducer 110, a modal converter 112, and abody 114. The transducer 110 and the modal converter 112 are mounted tothe body 114. The modal converter 112 provides a grating on the surfaceof the transducer 110 to direct the ultrasonic waves in a predetermineddirection. Selection of the grating pattern and the grating spacing ofthe modal converter 112 enables the longitudinal waves emitted from thetransducer 110 to undergo an angular shift.

FIG. 9 illustrates a third embodiment of the modal converter assembly,generally indicated by reference numeral 200. The modal converterassembly 200 includes a piezoelectric element 210, a modal converter212, and a body 214. The piezoelectric element 210 and the modalconverter 212 are mounted within the body 214. The piezoelectric element210 is mounted at an angle relative the bottom surface of the body 210.The modal converter 212 redirects the waves produced by thepiezoelectric element 210.

FIG. 10 illustrates a fourth embodiment of the modal converter assembly,generally indicated by reference numeral 300. The modal converterassembly 300 includes a piezoelectric element 310 and a modal converter312. In this embodiment, the modal converter 312 also functions as ahousing or body for the piezoelectric element 310. The piezoelectricelement 310 is mounted at an angle relative the bottom surface of themodal converter 312. The modal converter 312 redirects the wavesproduced by the piezoelectric element 310.

FIG. 11 illustrates a fifth embodiment of the modal converter assembly,generally indicated by reference numeral 400. The modal converterassembly 400 includes a plurality of transducers 410, 412, 414, 416. Thetransducers 410, 412, 414, 416 produce corresponding waves 420, 422,424, 426. A system controller, similar to the system controller shown inFIG. 1, can be used to control the engagement of each respectivetransducer 410, 412, 414, 416. Thus, as an example, the systemcontroller can sequentially engage each transducer 410, 412, 414, 416 toprovide gross angular shear or longitudinal waves. By controlling thetime delay between sequential operations of the transducers 410, 412,414, 416, the modal converter assembly 400 can provide waves at apredetermined angle. Thus, the modal converter assembly 400 can controlthe amount of delivered shear and/or longitudinal waves.

As shown in the embodiments, the piezoelectric may deliver shear wavesas a therapy by changing the angle of the piezoelectric transducerrelative to the medium either physically or temporally. Materials suchas a modal converter may be shaped to adjust the angle of thepiezoelectric relative to the medium. Additionally, multiplepiezoelectric elements may be used sequentially to achieve a similareffect.

As various modifications could be made to the exemplary embodiments, asdescribed above with reference to the corresponding illustrations,without departing from the scope of the invention, it is intended thatall matter contained in the foregoing description and shown in theaccompanying drawings shall be interpreted as illustrative rather thanlimiting. Thus, the breadth and scope of the present invention shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims appendedhereto and their equivalents.

1. A device for healing tissue, the device comprising: a transducerconfigured to transmit acoustic waves into the tissue from a tissuesurface; and a body configured to house the transducer above the tissuesurface, wherein the acoustic waves are transmitted into the tissue asshear waves and longitudinal waves to treat a damaged portion of thetissue, the acoustic waves being temporally shifted such that a sum ofthe acoustic waves transmitted into the tissue are transmitted at anoblique angle relative to the tissue surface.
 2. The device of claim 1,wherein the transducer includes a piezoelectric element.
 3. The deviceof claim 1, further comprising a spring configured to bias thetransducer toward the tissue surface.
 4. The device of claim 3, furthercomprising a cap configured to attach to the body, the spring having afirst end and a second end, the first end being attached to the cap andthe second end being attached to the transducer.
 5. The device of claim1, wherein the transducer comprises a plurality of acoustic wavegenerating elements oriented along the tissue surface.
 6. The device ofclaim 5, wherein the device is configured for controlling a time delaybetween sequential operations of the plurality of acoustic wavegenerating elements such that an amount of the shear waves and thelongitudinal waves delivered into the tissue are controlled.
 7. Thedevice of claim 1, further comprising a signal generator that isconfigured to control the acoustic waves transmitted by the transducer.8. The device of claim 1, wherein the oblique angle is in a range fromabout 18 to 71 degrees from normal.